Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Zimmer Biomet is updating instructions for Polaris and Cypher spinal screws to warn against using them with direct current stimulation due to construct failure risks.
Taro Pharmaceuticals is recalling Rite Aid Clotrimazole Cream because an unknown degradation impurity was detected slightly above the specification limit.
Out of the Kitchen, LLC is recalling specific bottles of Chef Mitch Maier's Black Garlic Ketchup because they may develop mold before the expiration date.
Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.
Helena Laboratories is recalling K-ACT Actalyke Clotting Test Tubes due to complaints of cracked or split caps.
Out of the Kitchen, LLC is recalling specific bottles of Chef Mitch Maier's Black Garlic BBQ Sauce because they may develop mold before the expiration date.
Dreyers Grand Ice Cream is recalling Outshine Fruit & Cream Bars due to complaints of foreign material in the ice cream bars.
AvKARE Inc. is recalling 38,715 bottles of Sildenafil 100 mg tablets because they were inadvertently packaged with trazodone at a third-party facility.
Simex Logistics SA de CV is recalling Lavar 70 Gel Hand Sanitizer because it is a subpotent drug. The product was distributed in California, Georgia, Nevada, and Texas.
Taro Pharmaceuticals is recalling Kroger Athlete's Foot Cream because an unknown degradation impurity was detected slightly above the specification limit.
Roche is recalling Tina-quant C-Reactive Protein Gen.3 reagents due to cross-contamination causing invalid calibrations and low quality control recovery.
Zydus Pharmaceuticals is recalling 22,848 cartons of Lansoprazole 30 mg tablets nationwide because they failed to meet dissolution specifications.
Taro Pharmaceuticals is recalling TopCare Clotrimazole Cream because an unknown degradation impurity was detected slightly above the specification limit.
Out of the Kitchen, LLC is recalling specific bottles of Chef Mitch Maier's Black Garlic Sauce because they may develop mold before the expiration date.
Taro Pharmaceuticals is recalling Equate Athlete's Foot cream because an unknown impurity was detected above specification limits.
Fusion Health and Vitality LLC is recalling Pharmorigins Core dietary supplements due to the unapproved use of a food additive and unapproved marketing statements.
Simex Logistics SA de CV is recalling +Protec Hands Antibacterial Gel because it is subpotent. The product was distributed in California, Georgia, Nevada, and Texas.
Taro Pharmaceuticals is recalling HEB Clotrimazole Cream 1% because an unknown degradation impurity was detected slightly above the specification limit.
USDA FSIS issued a public health alert for raw frozen chicken wings from China labeled with a false USDA mark. No recall was requested as the product is no longer in commerce.
Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.
JMH International is recalling Chef Myron's Eurasian Fusion Sauce because it contains wheat-derived fermented soy sauce despite a gluten-free claim.
Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.
JMH International is recalling Chef Myron's Yakitori Sauce because it contains wheat-derived ingredients despite a gluten-free claim.
Integra LifeSciences Corp. is recalling 552 instruction manuals for the Mayfield A2000 Skull Cap to correct inaccurate illustrations.
LivaNova is recalling eight SENTIVA DUO VNS Therapy generators because they display the incorrect model number after a device reset.